New York Patients who participated in a recent clinical trial for an aggressive cancer treatment may have suffered fatal injuries as a result. This can present numerous concerns and questions for family members whose lives will never be the same.
Why Clinical Trials Are Different
In a traditional treatment setting, such as a hospital, a physician is responsible for ensuring the proper standard of care for every single patient. Manufacturers of prescription drugs or medical devices may be found liable if their approved drugs and devices are later found to be defective and hazardous. When it comes to a test-run of a clinical trial, however, usually patients are asked to sign waivers at the outset of the treatment. Most understand that there are no guarantees about whether or not the treatment will be effective since the treatment is new. That does not always mean, however, that the developers or study managers are absolved of all liability if something goes wrong.
What’s Required for Clinical Testing
In order to get to the point of testing on humans, drug and treatment developers in New York should have conducted comprehensive testing in order to determine any potential risks. As the recent Juno clinical trial illustrated, however, sometimes the impacts can be catastrophic. Patients participating in Juno Therapeutics’ recent clinical trial for cancer treatment may be at severe risk of fatal injuries. Five lives have already been claimed in this clinical trial.
In 2005, there were around 6,000 registered clinical trials in the U.S. In 2013, however, that number grew dramatically to more than 160,000. The reality is that the use of clinical trials is on the rise, but that those rushed to the trial stage too quickly could injure or kill patients unnecessarily.
The clinical trial was in Phase II when several patients passed away due to swelling in the brain. The clinical trial was put on hold twice as a result of these issues. The company was calling their treatment a “Rocket” drug for B cell acute lymphoblastic leukemia. The treatment was officially referred to as JCAR015 and was designed for use with adult patients.
While consent forms are nearly always used in these kinds of trials, it can be a challenge to have these upheld in court if there are any provisions barring the patient from filing a legal claim. Family members may be entitled to pursue a wrongful death lawsuit with the help of an experienced attorney in the event that the developer of the drug or the study manager were negligent or reckless in any way. Failing to complete comprehensive testing well in advance, for example, could indicate that deaths may have been prevented.
As each case is unique, family members of any individuals hurt or killed in the Juno Therapeutics JCAR015 clinical trial in New York need to set up a consultation immediately with an attorney. The issues involved in pursuing a case are extremely complex and should only be handled by a dedicated and experienced lawyer. Do not wait to get the help you need from an attorney if you have recently lost a loved one in a clinical trial. You may be able to pursue a legal claim.
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